Kornimate/medical-research-clean huggingface dataset:
effectiveness study of the biovac direct suction device in upper gastrointestinal bleeding

Conditions: Gastrointestinal Hemorrhage

Summary: upper endoscopy is performed for upper gastrointestinal bleeding (bleeding in the esophagus, stomach, or part of the duodenum) to identify and potentially treat the cause of bleeding. however, blood clots often make visualization difficult during endoscopy. the current practice is to try to wash off and suction up these blood clots with the endoscope. however, this is often not successful due to blood clots blocking the suction channel. a new device has been approved by health canada that attaches to the endoscope and helps prevent blockage. it is believed that this device will help doctors suck out blood clots and potentially improve visualization, identification of the cause of bleeding, and possibly health outcomes, although this has never been proven. the purpose of the this clinical trial is to test whether the device works and whether it can help patients with this type of bleeding.

study design: this is a randomized double blind clinical trial of the biovac suction device versus standard endoscopy suction for ugib. the study will be performed at london health sciences center victoria campus and university campus with an anticipated recruitment period of 2.5 years. study population: all patients over the age of 18 admitted to hospital with a diagnosis of ugib will be considered for recruitment. patients already admitted to hospital with another diagnosis who develop ugib will also be included. intervention: patients will undergo egd for ugib as per standard clinical practice. if the bleeding source is not found within the first 5 minutes (timer starts once egd passes upper esophageal sphincter) due to blood clots, the patient may benefit from additional suctioning. the patient will be randomized in blocks of 2-6 stratified by site to either the biovac device or endoscopy suction. those randomized to the biovac device will use it to irrigate and suction as much blood as possible until the bleeding source is found or until the endoscopist feels that additional time would not help. those randomized to endoscopy suction will do the same without the biovac device. due to the suctioning power of the study device, a placebo is not possible. our original intention was to record the endoscopy video to blindly assess the outcome. unfortunately, this ended up not being possible for technical reasons.

Eligibility criteria:
inclusion criteria 1. patients presenting with fresh blood hematemesis, coffee ground emesis, or melena 2. patients with hematochezia and hypotension (systolic blood pressure \ 110 beats per minute) exclusion criteria 1. identification of a bleeding source within the first 5 minutes of the upper endoscopy or no blood seen in the upper gi tract as these patients do not require additional suctioning. 2. age \< 18. 3. no endoscopy was performed. 4. endoscopy previously performed for current episode of ugib. 5. patients unable to consent and who do not have a substitute decision maker.

Keywords: upper gastrointestinal tract endoscopy endoscopic hemostasis
pulses of vincristine and dexamethasone in bfm protocols for children with acute lymphoblastic leukemia

Conditions: Acute Lymphoblastic Leukemia

Summary: studies in the 1970s and 1980s suggested that the outcome of childhood acute lymphoblastic leukemia could be improved by intensification of conventional continuation chemotherapy with pulses of vincristine sulfate and steroids. we aimed to investigate the efficacy and toxic effects of vincristine-dexamethasone pulses as an addition to the continuation-therapy phase in a large cohort of children with intermediate-risk disease who were treated with the bfm treatment strategy

the study enrols children from 8 participating organizations. all children are treated with similar protocols based on the bfm treatment strategy, which include induction, consolidation, reinduction and continuation-therapy phases. at the beginning of the continuation-therapy phase, those patients in complete remission are randomly assigned to either a treatment or a control group. control patients are given conventional mercaptopurine and methotrexate chemotherapy only. patients in the treatment arm are also given pulses of vincristine (1.5 mg/sqm weekly for 2 weeks) and dexamethasone (6 mg/sqm daily for 7 days) every 10 weeks for six cycles.

Eligibility criteria:
inclusion criteria: * age \ 5 years or * white blood cell count at diagnosis \>=20000 exclusion criteria: * prednisone poor response * no complete remission at the end of induction (ia) * t(9,22) clonal translocation * t(4,11) clonal translocation

Keywords: acute lymphoblastic leukemia, maintenance, bfm protocol intermediate risk childhood acute lymphoblastic leukemia
"pi" and hot flushes

Conditions: Menopausal Symptom Relief

Summary: hot flushes are common symptoms in women after menopause, and are important causes of discomfort and lead to high number of medical consultations. hormone replacement therapy is an effective treatment, however it can bring undesirable consequences and may be contraindicated for some women. options are inhibitors of serotonin or serotonin-norepinephrine reuptake, gabapentin, herbal medicines and homeopathy. none of these therapies is widely accepted of effective. therefore, the search for new therapeutic options is highly desirable. ingestion of malagueta pepper fruits (capsicum frutescens l. var. malagueta) causes sensations similar to those experienced by menopausal women during hot flushes. by the principle of homeopathy, "the like cures the like", the objectives of this study are: (a) to determinate whether pathogenesis of a homeopathic medicine made from c. frutescens fruits include symptoms like hot flushes, and (b) whether this medicine is effective on hot flushes relief in women after menopause. there will be 2 distinct phases. phase 1 is the determination of the medicine's pathogenesis in healthy volunteers, in a randomized placebo-controlled, double-blind design. phase 2 is the investigation of the medicine's effects on hot flushes of women after menopause, in a randomized placebo-controlled, double-blind design. the investigators expect a significant reduction on symptoms perception, assessed by internationally validated tools. the study is expected to last for 18 months, with 36 patients included in each phase.


Eligibility criteria:
inclusion criteria: * phase 1: healthy volunteers * phase 2: menopaused women with hot flushes exclusion criteria: * illiteracy; * have been enrolled in another clinical trial within the last 6 months; * use of pharmacological therapies for hot flushes; * have any degree of vulnerability; * allergy or hypersensitivity to capsicum species;
reducing pain and increasing comfort during a retinopathy of prematurity examination

Conditions: Pain; Retinopathy of Prematurity; Premature Baby 26 to 32 Weeks; Premature Baby 33 to 36 Weeks

Summary: the aim of this study is to investigate the effect of baby massage applied to babies with retinopathy of prematurity on the pain and comfort of the newborn. this was randomised-controlled study in the nicu at the health sciences university bursa high specialization training and research hospital, bursa, turkey. the population of the study will consist of preterms hospitalized in the neonatal intensive care unit during the time period of the study. in the calculation of the sample size, the power level was 80% and the significance level was 5%. when the effect size was determined as 0.8 in the examination of the difference between the experimental and control groups in terms of the premature infant pain profile (pipp) variable, it was determined by the statistical expert that the number of babies to be included in each group was 26 and 52 babies in total should be included in the study. based on this, the study sample was determined as 60 preterm infants in 30 experimental and 30 control groups. block randomization method will be applied in the randomization of the groups. case report form, pipp=premature infant pain scale and premature infant comfort scale (pbiq) will be used to collect the study data. patients included in the study will be examined by the same ophthalmologist. the infant massage to be applied before the examination will be applied by a single nurse=researcher. video recordings will be taken before and during the rop examination and evaluations will be made by two neonatal nurses other than the researcher. infants will be massaged by the researcher in accordance with iaim guidelines and massage techniques. total massage time will be equal for each infant. the researcher has an iaim infant massage certificate. before starting the infant massage, jewelry will be removed and hands will be washed. in the study, leg and face massage will be applied among the massage techniques in the iaim guidelines.


Eligibility criteria:
inclusion criteria: * \<32 gestational age * birth weight of \<1500g * who were clinical stable * baby's first eye examination * the baby's family has permission exclusion criteria: * infants with previous rop examination * lack of mechanical ventilator support * major congenital anomaly * intraventriculer bleeding * receiving analgesic medication
study electromyographic activity of the muscles of the pelvic floor runners with conventional shoes and minimalist.

Conditions: Stress Urinary Incontinence

Summary: justification: urinary incontinence is highly prevalent among women who play high impact sports such as running. that observed one of the possible reasons for this high prevalence is delayed activation of the pelvic floor in relation to the abdominal muscles. the use of minimalist shoes during the race produces changes in muscle and joint biomechanics and efficiency in the race. however, to date no studies evaluating the influence of footwear in the musculature of the pelvic floor during the race. objective: describe and compare the electromyographic activity of the muscles of the pelvic floor and abdominal during the race with conventional shoes and minimalist. design: cross-over study experimental, analytical and prospective. methodology: conventional and minimalist: 50 healthy young women, 6- randomly distributed in two groups will be included to characterise the electromyographic activity of the pelvic floor muscles before and during running at 6-9-11 km/h with the two types of running shoes. a baseline assessment will be performed to confirm that the women meet the inclusion and exclusion criteria. the ability to run a 10-minute treadmill at a speed of 6-9-11 km/h will be assessed, as well as the ability to adequately contract the pelvic floor muscles. the group of 50 women will initially run randomly with conventional running shoes or with minimalist running shoes, and then, after a 10-minute washout period, will run with the other type of running shoe, i.e. if a participant in the first phase used conventional running shoes, she will run with a minimalist running shoe in the second phase. the cadence of step, the range of movement of the femur and the emg recording with electromyographic sensors of the pelvic floor musculature (using an intravaginal probe of the germproof brand), abdominal (internal and external oblique), spinal erectors and gluteus (using a surface sensor) in relation to the cycling gait will be collected and recorded with barographic sensors. the variables to be included in the electromyography for each muscle in relation to the gait cycle will be: onset of activation, duration, intensity and synergy with their corresponding standard deviation.


Eligibility criteria:
inclusion criteria: * women aged 18 to 38 years. * nulliparous. * clinically healthy at the time of the study. * physically able for the requirement of the race on tape. * body mass index (bmi) 20-25 kg / m2 * having signed the informed consent. exclusion criteria: * pregnant women. * urogynecological dysfunction. * lower limb surgeries performed in the last six months. * not be able to make voluntary contractions of the pelvic floor standardized according to the modified oxford scale

Keywords: pelvic floor electromyography barefoot
feasibility study of glaxosmithkline biologicals' gsk2202083a vaccine in healthy infants at 3, 5 and 11 months of age.

Conditions: Tetanus; Poliomyelitis; Neisseria Meningitidis; Haemophilus Influenzae Type b; Diphtheria; Acellular Pertussis; Hepatitis B

Summary: this study will evaluate the safety and immunogenicity of gsk biologicals' gsk2202083a vaccine given as a three-dose vaccination course at 3, 5 and 11 months of age.


Eligibility criteria:
inclusion criteria: * a male or female infant between, and including, 8 and 16 weeks at the time of the first vaccination. * born after a gestation period of 36 to 42 weeks inclusive. * subjects who the investigator believes that their parents/ guardians can and will comply with the requirements of the protocol. * written informed consent obtained from the parent or guardian of the subject. * healthy subjects as established by medical history and clinical examination before entering into the study. exclusion criteria: * use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period. * chronic administration of immunosuppressants or other immune-modifying drugs since birth. * administration of immunoglobulins and/or any blood products since birth or planned administration during the study period. * administration of a vaccine not foreseen by the study protocol within 30 days prior to randomisation, or planned administration from randomisation to study visit 3, or from 30 days before to 30 days after study visit 4, with the exception of influenza and human rotavirus vaccines. the administration of other vaccines, including conjugated pneumococcal vaccine, is allowed during the period from one day after study visit 3 to 31 days before study visit 4. * concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product * evidence of previous or intercurrent diphtheria, tetanus, pertussis, hepatitis b, poliomyelitis, hib and/or menc vaccination or disease, including hbv vaccination at birth. * history of seizures or progressive neurological disease. * any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. * history of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s). * major congenital defects or serious chronic illness. the following condition is temporary or self-limiting, and a subject may be vaccinated once the condition has resolved if no other exclusion criteria is met: • current febrile illness or axillary temperature \>= 38.5 ºc or other moderate to severe illness within 24 hours of study vaccine administration

Keywords: combined vaccine primary vaccination
four week safety and efficacy study with a topical gel to treat common warts in adults

Conditions: Warts

Summary: the primary purpose of this study is to evaluate the effectiveness in adults, of four different strengths of resiquimod gel applied to common wart(s) three times a week for four weeks. a second purpose is to evaluate the safety of the drug.


Eligibility criteria:
inclusion criteria: * diagnosis of common warts * two forms of birth control exclusion criteria: * pregnant or breast feeding * other types of warts, ie. plantar * currently participating in another clinical study * chronic viral hepatitis b or c

Keywords: wart(s) adults common wart(s)
a comparison of azopt versus placebo added to xalatan in patients with elevated intraocular pressure (iop) on a prostaglandin

Conditions: Glaucoma

Summary: the purpose of this study was to assess the efficacy of adding azopt dosed three times a day to xalatan as compared to that of adding placebo to xalatan in patients with elevated intraocular pressure.


Eligibility criteria:
inclusion criteria: * unilateral or bilateral primary open angle glaucoma, ocular hypertension or pseudoexfoliation syndrome. * intraocular pressure greater than 18 mmhg (mean diurnal) and less than 32 mmhg. * other protocol-defined inclusion criteria applied. exclusion: * previous intraocular surgery, except uncomplicated clear cornea phacoemulsification or argon laser trabeculoplasty. * argon laser trabeculoplasty or phacoemulsification within the last 3 months. * central corneal thickness outside the 500 - 600 (inclusive) micron range as measured by ultrasonic pachymetry. * ocular or periocular inflammation within 3 months prior to study (except blepharitis related or seasonal allergic conjunctivitis). * history of uveitis or previous intraocular inflammation (other than post-operatively). * hypersensitivity to sulfa, or benzalkonium chloride. * history of use of any steroids for over 1 week within 3 months of screening or likely need for any corticosteroids during the study (except inhaled, nasal or topical non-ocular). * other protocol-defined exclusion criteria applied.

Keywords: glaucoma
intervention mapping to adapt a mindfulness-based intervention for adults with diabetes and emotional distress

Conditions: Type 2 Diabetes; Stress

Summary: we will conduct a single-arm pilot study of an integrated mindfulness-based stress reduction (mbsr)/diabetes self-management education (dsme) intervention in a small group of participants, low-income adults with type 2 diabetes and diabetes distress. we will evaluate the preliminary efficacy, acceptability, and feasibility of the intervention.

the intervention will comprise components of mbsr and dsme and will be delivered in a group setting with 8 weekly sessions. we anticipate enrollment of 30 participants, who will be adults with poorly controlled type 2 diabetes and elevated diabetes distress recruited from cooper green mercy health systems, a safety-net health system serving residents of jefferson county, alabama. a trained masters-level interventionist will deliver the integrated intervention. the aim of the intervention is to reduce diabetes distress and improve glycemic control. participants will be assessed at baseline and 2 months. we will assess the preliminary efficacy of the intervention through pre/post evaluation of diabetes distress, diabetes self-management behaviors, and glycemic control as measured by hemoglobin a1c. additionally, we will assess acceptability of the intervention through follow-up qualitative, focus groups with intervention participants; the feasibility of intervention delivery will be assessed using process measures.

Eligibility criteria:
inclusion criteria: * type 2 diabetes * receipt of care at cooper green mercy healthcare system (cgmhs), one or more visits to primary care or diabetes clinic within the prior year * an elevated point-of-care hemoglobin a1c (a1c) ≥7.5 * presence of moderate diabetes distress (indicated by a score of ≥2 on the diabetes distress scale) exclusion criteria: * non-english speaking * currently pregnant * personal history or prior diagnosis of bipolar disorder, schizophrenia, or psychosis

Keywords: diabetes distress mindfulness-based intervention diabetes self-management education
the construction and validation of cansrint

Conditions: Hearing Loss

Summary: an open-set sentence speech recognition in noise test in cantonese chinese, which is applicable on children and adults with hearing impairment, is proposed to be developed in this project.

introduction: speech recognition in noise is an important aspect of human communication. one's speech recognition ability in noise is inevitably affected by any hearing impairment, and may only be quantified with specific language at an appropriate difficulty. there is a niche among clinically available test materials between word recognition and 10- syllable sentence recognition in noise in cantonese chinese. ten-syllable sentence items are commented to be too challenging to young children and elderly population. an assessment tool for pediatric patients, and the whole spectrum of patients with significant hearing impairment, compromised language or cognitive abilities, is deemed necessary. both the research and clinical audiology communities need a valid and reliable outcome measurement tool for sentence recognition abilities in noise of the specific population. an open-set sentence speech recognition in noise test in cantonese chinese, which is applicable on children and adults with hearing impairment, is proposed to be developed in this project to bridge the gap. methods: thirty three participants with typical hearing, from each of the 5 age groups from their 6 years of age to adulthood, will be recruited to contribute to the normative data of the proposed test. one hundred participants with various degree of hearing impairment will be recruited for the validation of the proposed new test as well. a sentence pool of at least 150 sentence items will be constructed based on the basic sentence syntax in cantonese chinese. each sentence item will be 7 syllables in length on average. the words used in the sentences will be words frequently used in daily life by both persons with typical hearing and hearing impairment. a 4-talker babble in cantonese chinese will be generated as the competing noise in this proposed new test. outcomes: by rasch modelling, sentence items with high probability of consistently and accurately estimating sentence recognition ability in noise across different participants will be selected and distributed to a few parallel lists. rater and test-retest reliability of the test items and lists will be established. content-related and construct-related evidence of validity of lists will also be supported by psychometric analyses as well as expert consultation. application: a valid and reliable assessment tool, of sentence recognition ability in noise in cantonese, applicable to persons with hearing sensitivity ranging from profound impairment to typical, in both the research and clinical audiology fields, will be constructed.

Eligibility criteria:
inclusion criteria: * native in catonese exclusion criteria: * have overall cognitive and developmental impairment
peripheral insulin uptake in type 2 diabetes mellitus and in non-diabetic individuals

Conditions: Type 2 Diabetes Mellitus

Summary: impaired uptake of glucose by skeletal muscle is a key feature of type 2 diabetes mellitus. it is unclear to what extent impaired insulin uptake from capillaries into skeletal muscle interstitium plays a role in this process. we hypothesize that impaired uptake of insulin from capillaries into skeletal muscle interstitium is involved in impaired glucose uptake by skeletal muscle in type 2 diabetes mellitus.


Eligibility criteria:
inclusion criteria for all participants: * written informed consent * hemodynamically stable with a systolic blood pressure \> 100 mmhg * medical need to undergo a cag procedure as determined by cardiologist exclusion criteria for all participants: * ongoing myocardial infarction as determined from elevated cardiac markers * participation in an investigational trial within 90 days prior to present study * donation of blood (\> 100 ml) within 90 days prior to present study * serious mental impairment or language problems i.e. preventing to understand the study protocol/aim * use or recent use (within 3 months of study participation) of oral glucocorticoids inclusion criteria for non-diabetic individuals: * 30 years ≤ age ≤ 80 years (extremes included) * fasting glucose level of \< 7.0 mmol/l and hba1c \< 6.5% (= \< 48 mmol/mol) exclusion criteria for non-diabetic individuals: - known t2dm/use of glucose-lowering medication inclusion criteria for t2dm patients: * 30 years ≤ age ≤ 80 years (extremes included) * fasting glucose level of \> 7.0 mmol/l, or hba1c \> 6.5 (= \> 48 mmol/mol) or known t2dm exclusion criteria for t2dm patients: - treatment with insulin preparations